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October 31, 2005

Use of “bioidentical” female hormones questioned

by Sam Savage

By Deena Beasley

LOS ANGELES (Reuters) - There is no evidence that so-called
"bioidentical hormones" are safer than synthetic hormones for
menopausal women and there is a risk that they may not meet
quality standards, a medical group warned on Monday.

"There are a growing number of women who are seeking
therapy with bioidentical hormones, but there is a lot of
misinformation about the assertion that these are plant-derived
and therefore more closely mimic the estrogen that is in a
woman's body," said Dr. Michele Curtis, associate professor of
obstetrics and gynecology at Houston's University of Texas
Medical School.

Sales of female hormone replacement drugs, such as Wyeth's
Premarin, have plummeted in the wake of a U.S.-financed study
that uncovered health risks associated with their long-term
use.

Compounded "bioidentical hormones" are plant-derived
hormones that are prepared and packaged as a drug by a
pharmacist.

The formulations present the same risk as commercial drugs,
but because they are unregulated, patients may not be informed
of the risk, the American College of Obstetricians and
Gynecologists said.

The U.S. Food and Drug Administration requires drugmakers
of FDA-approved products that contain estrogen and progestogen
to include a warning about increased risk of heart disease.

Compounded products are not approved by the FDA and
pharmacies offering these products are exempt from including
the warnings.

"These are hormones. They act just like estrogens that are
commercially produced," Curtis said.

QUESTIONS ABOUT QUALITY

The ACOG also said most compounded products, including
bioidentical hormones, have not undergone rigorous clinical
testing and there are concerns regarding their quality.

In 2001, the FDA analyzed a variety of 29 product samples
from 12 compounding pharmacies and found that 34 percent of
them failed one or more standard quality tests, the group said.

"When a pharmacist compounds a drug, there is no way to
know the concentration or to be sure that a patient is getting
the same product every time," said Stephen Simes, chief
executive of BioSante Pharmaceuticals, which expects to file
this year for FDA approval of a patch that delivers
bioidentical hormones through the skin.

He said bioidentical hormones might be safer than
commercial hormone replacement therapy, but so far there have
been no long-term studies to find out.